Image-Guided Surgery in Patients with Pancreatic Cancer: First Results of a Clinical Trial Using SGM-101, a Novel Carcinoembryonic Antigen-Targeting, Near-Infrared Fluorescent Agent

Abstract

BackgroundNear-infrared (NIR) fluorescence is a promising novel imaging technique that can aid in intraoperative demarcation of pancreatic cancer (PDAC) and thus increase radical resection rates. This study investigated SGM-101, a novel, fluorescent-labeled anti-carcinoembryonic antigen (CEA) antibody. The phase 1 study aimed to assess the tolerability and feasibility of intraoperative fluorescence tumor imaging using SGM-101 in patients undergoing a surgical exploration for PDAC.MethodsAt least 48 h before undergoing surgery for PDAC, 12 patients were injected intravenously with 5, 7.5, or 10 mg of SGM-101. Tolerability assessments were performed at regular intervals after dosing. The surgical field was imaged using the Quest NIR imaging system. Concordance between fluorescence and tumor presence on histopathology was studied.ResultsIn this study, SGM-101 specifically accumulated in CEA-expressing primary tumors and peritoneal and liver metastases, allowing real-time intraoperative fluorescence imaging. The mean tumor-to-background ratio (TBR) was 1.6 for primary tumors and 1.7 for metastatic lesions. One false-positive lesion was detected (CEA-expressing intraductal papillary mucinous neoplasm). False-negativity was seen twice as a consequence of overlying blood or tissue that blocked the fluorescent signal.ConclusionThe use of a fluorescent-labeled anti-CEA antibody was safe and feasible for the intraoperative detection of both primary PDAC and metastases. These results warrant further research to determine the impact of this technique on clinical decision making and overall survival.

Elevated CEA and CA19-9 serum levels independently predict advanced pancreatic cancer at diagnosis

“…laparoscopic ultrasound or near-infrared fluorescence imaging) should also be considered in this patient category. Preliminary results showed that CEA-targeting near-infrared fluorescence imaging is promising for intraoperative evaluation of locoregional status and detection of distant metastases and further studies defining clinical benefit are ongoing (Gutowski et al 2017, Hoogstins et al 2018.…”

Identifying Biomarkers in Lymph Node Metastases of Esophageal Adenocarcinoma for Tumor-Targeted Imaging

“…EpCAM and CEA seem of particular interest for clinical translation given our current findings. Recently, a CEA-targeted fluorescent probe for intraoperative imaging, SGM-101, was validated in 26 patients with colorectal cancer [27] and 12 patients with pancreatic cancer [28]. Results indicated that the probe was safe and feasible for visualizing both primary adenocarcinomas and small metastases.…”

Carcinoembryonic antigen-specific, fluorescent image-guided cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for metastatic colorectal cancer

“…Near‐infrared (NIR) fluorescence imaging techniques using tumour‐targeting tracers may aid in this respect. In recent years, fluorescence‐guided surgery has gained interest, and has been able to provide surgeons with real‐time feedback and visualization of malignant tissues. SGM‐101, a carcinoembryonic antigen (CEA)‐specific tumour‐targeted fluorescent agent, can be used for fluorescence imaging to identify malignant tissue of colorectal origin.…”